India's first coronavirus vaccine COVAXIN, by Hyderabad-based Bharat Biotech, is expected to begin human trials of its candidate by next week. COVAXIN, which is India’s first indigenous vaccine against the novel coronavirus (COVID-19) and has been developed by Bharat Biotech in collaboration with ICMR and NIV, Pune. COVAXIN will be tested on more than 1,100 people in phase 1 and 2 clinical trials, in which more than 1,100 people are expected to be enrolled
Last week, the inactivated coronavirus vaccine received DCGI approval for phase 1 and 2 clinical trials. COVAXIN is derived from a strain of SARS-CoV-2 virus isolated in NIV, Pune, and transferred to Bharat Biotech to develop into a vaccine candidate.
In phase 1, Bharat Biotech plans to enrol 375 people for the clinical trials scheduled that are scheduled to start next week and 750 people will enrol in the second phase. The company has set July 13 as the final date of enrollment for the trials. The company said COVAXIN has demonstrated safety and immune response in preclinical studies.
In phase 1, they will be split into three groups of 125 and be administered two doses - one each of the candidate and control vaccine - 14 days apart. Pending satisfactory completion of Phase I, a further 750 participants will be registered for Phase II of the clinical trials.
According to the application made by Hyderabad-based Bharat Biotech, the timeframe for Phase I is 28 days, which means the trial must start by July 18 to meet the government's promise of releasing a vaccine by August 15. However, the August 15 target was criticised by experts who said that fast-tracking vaccine trials in four weeks could pose serious health risks.